Ace Surigical Tru-Fix Implant System, Model 454-180X-XX
FDA 510(k) K080074 · Ace Surgical Supply Co., Inc.
510(k) numberK080074
Submission
- Device name
- Ace Surigical Tru-Fix Implant System, Model 454-180X-XX
- Applicant
- Ace Surgical Supply Co., Inc.
Brockton, MA, US - Received
- January 11, 2008
- Decision date
- February 14, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…OAT · Traditional | 08/16/2006SE |
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| K041759 | Ace Connect Internal ConnectionDZE · Special | 07/22/2004SE |
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Questions and answers
When was Ace Surigical Tru-Fix Implant System, Model 454-180X-XX cleared by the FDA?
Ace Surigical Tru-Fix Implant System, Model 454-180X-XX (K080074) received a 510(k) decision of Substantially Equivalent on February 14, 2008, 34 days after the submission was received.
What is the product code of K080074?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.